Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Exacerbations of hepatitis B [see Boxed Warning , Warnings and Precautions (5.1) ].
Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.2) ].
Pancreatitis [see Warnings and Precautions (5.3) ].
Immune reconstitution syndrome [see Warnings and Precautions (5.4) ].
The most common reported adverse reactions (incidence greater than or equal to 15%) in adults were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough.
( 6.1 ) The most common reported adverse reactions (incidence greater than or equal to 15%) in pediatric subjects were fever and cough.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell Governmental & Specialty RX, LLC.
at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety profile of lamivudine in adults is primarily based on 3,568 HIV-1-infected subjects in 7 clinical trials.
5 WARNINGS AND PRECAUTIONS Co-infected HIV-1/HBV Patients: Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported.
( 5.1 ) Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues.
( 5.2 ) Pancreatitis: Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis.
Discontinue treatment as clinically appropriate.
( 5.3 ) Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.
Like all medications, Lamivudine can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: